An epidemiological investigation of high-risk children for Respiratory Syncytial Virus infections - RWE palivizumab utilization as a RSV preventive treatment in Lazio (Italy)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49569
• EU PAS number:
  EUPAS49568
• Study ID:
  49569
• Official title and acronym:
  An epidemiological investigation of high-risk children for Respiratory Syncytial Virus infections - RWE palivizumab utilization as a RSV preventive treatment in Lazio (Italy)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The overall objective of the study will be to perform a descriptive analysis of a series of aspects related to respiratory syncytial virus infection in high-risk children, such as drug utilization, hospitalizations and related hospital procedures.
• Study status:
  Ongoing

Research institution and networks

Institutions

Department of Epidemiology of the Regional Health Service - Lazio

Italy

Study timelines

Date when funding contract was signed

Planned: 23/06/2022

Actual: 23/06/2022

Study start date

Planned: 27/10/2022

Actual: 27/10/2022

Date of final study report

Planned: 31/12/2022

Sources of funding

Other

More details on funding

IQVIA Solutions SPA

Study protocol

Initial protocol

Protocol_RSV_Palivizumab

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Prot. N. 1133/CE Lazio 1